Clinical Trial: Sorafenib in Treating Patients With Metastatic Breast Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase II Trial of Raf Kinase Inhibitor BAY 43-9006 as Single Oral Agent in Patients With Metastatic Breast Cancer Previously Exposed to Anthracycline and/or Taxane

Brief Summary: This phase II trial is studying how well sorafenib works in treating patients with metastatic breast cancer. Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor.

Detailed Summary:

OBJECTIVES:

I. Determine the tumor response rate in patients with metastatic breast cancer previously treated with an anthracycline- and/or taxane-containing regimen receiving sorafenib.

II. Assess the toxicity profile of this drug in these patients. III. Determine time to disease progression and survival time of patients treated with this drug.

IV. Correlate pre-treatment levels of activated ERK1/2 with tumor response in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months until disease progression and then every 3 months for up to 5 years.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: Proportion of confirmed tumor responses, graded according to RECIST criteria [ Time Frame: Up to 5 years ]

A confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. The tumor response rate is defined as the total number of eligible patients who achieved a complete or partial response according to the RECIST criteria divided by the total number of eligible patients enrolled on study. A 90% confidence interval for the true response rate will be constructed using the Duffy-Santner approach.


Original Primary Outcome:

Current Secondary Outcome:

  • Time to progression [ Time Frame: Time from registration to disease progression, assessed up to 5 years ]
    Estimated using the Kaplan-Meier method.
  • Survival time [ Time Frame: Time from registration to death, assessed up to 5 years ]
    Estimated using the Kaplan-Meier method.
  • Incidence of adverse events, graded according to the NCI-CTC version 3 [ Time Frame: Up to 5 years ]
    The maximum grade for each type of toxicity will be recorded for each patient at each treatment evaluation. The frequency of each type of toxicity will be determined.


Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: November 9, 2004
Date Started: September 2004
Date Completion:
Last Updated: October 7, 2013
Last Verified: October 2013